Limbrel Lawsuit

Filing a Limbrel lawsuit may be an option for individuals who suffered drug-induced liver injury or hypersensitivity pneumonitis while taking this medical food product to treat osteoarthritis.

Contact a Limbrel Attorney Today

The nationwide law firm of Bernstein Liebhard LLP is offering free legal reviews to individuals who may have suffered Limbrel side effects, including drug-induced liver injury or hypersensitivity pneumonitis. To contact a Limbrel lawyer today, please fill out the form on this page or call (888) 994-5118.

Limbrel: What’s the Problem?

Marketed by Primus Pharmaceuticals, Limbrel (flavocoxid) was brought to market in 2004. It is currently regulated by the U.S. Food & Drug Administration (FDA) as a medical food. Medical foods are specially formulated and intended for the dietary management of a disease that has distinctive nutritional needs that cannot be met by normal diet alone. Unlike prescription drugs, such products do not have to undergo the FDA’s premarket review, registration or approval process.

Limbrel is available in two dosages (250 and 500 mg) and contains two types of flavonoids, as well as zinc. The product is intended to manage the metabolic processes associated with osteoarthritis.

In early September 2017, the FDA began investigating an increase in Limbrel adverse event reports, including drug-induced liver injury and a lung condition called hypersensitivity pneumonitis. On November 21, 2017, the agency issued a press release that warned consumers not to use Limbrel, after the product had been linked to 194 adverse event reports.

“In 30 of those cases, there was sufficient information for FDA medical experts to determine that Limbrel was likely associated with these adverse events,” the release stated.

That number increased to 200 reports by December 4, 2017.

One December 18, 2017, the FDA sent a letter to Primus Pharmaceuticals formally requesting a Limbrel recall. The letter indicated that the agency would designate the recall a Class I recall, a category that “represents a serious health hazard which may be life-threatening.”

Primus Pharmaceuticals voluntarily suspended promotion and sale of Limbrel on December 21st. However, the company had not announced a Limbrel recall as of January 2, 2018.

Limbrel Drug-Induced Liver Injury

The FDA’s investigation was not the first to suggest that Limbrel could harm the liver.

Among 877 patients enrolled in the study, four were diagnosed with liver injury. All were women from 57 to 68 years old, and all developed symptoms and signs of liver injury within 1 to 3 months after initiating flavocoxid. All patients recovered within 3 to 12 weeks after flavocoxid was stopped.